Accelerated Stress and Forced Degradation Study
Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package.
At Novabioassays we help the clients to choose the analytical method for characterizing samples generated from the stress and forced degradation study. The analytical method of choice should be sensitive enough to detect impurities at low levels (i.e., 0.05% of the analyte of interest or lower) and the peak responses should fall within the range of detector’s linearity. The analytical method should be capable of capturing all the impurities formed during a formal stability study at or below ICH threshold limits. Degradation product identification and characterization are to be performed based on formal stability results in accordance with ICH requirements. Use of the selected analytical techniques can provide a better insight into the structure of the impurities that could add to the knowledge space of potential structural alerts for genotoxicity and the control of such impurities with tighter limits.